BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 88C LEAD, 60CM LENGTH

    MDR report key: 2102856 · Received April 12, 2011

    Report

    Report Number
    1627487-2011-00656
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE 1627487-2011-00655. THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING A RECEIVER AND A SURGICAL LEAD ON (B)(6) 2004. IT WAS REPORTED THAT HE IS EXPERIENCING INTERMITTENT STIMULATION. IN AN EFFORT TO RECAPTURE EFFECTIVE THERAPY, SEVERAL EXTERNAL COMPONENTS OF THE PATIENT'S SCS SYSTEM WERE REPLACED, BUT THE REPORTED PROBLEM PERSISTS. A NEW TRANSMITTER WAS SHIPPED TO THE PATIENT AND A REPROGRAMMING APPOINTMENT WILL BE SCHEDULED AS MEANS OF FURTHER INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AS ALL ATTEMPTS TO CONFIRM RESOLUTION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88C LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3416 26489

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention